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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1986-09-09 to 1986-10-12
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Scientifically well performed study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report date:
1986

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Naphthenic acids, reaction products with diethylenetriamine
EC Number:
268-610-1
EC Name:
Naphthenic acids, reaction products with diethylenetriamine
Cas Number:
68131-13-5
Molecular formula:
not applicable
IUPAC Name:
Naphthenic acids, reaction products with diethylenetriamine

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
occlusive
Preparation of test site:
not specified
Vehicle:
physiological saline
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml


Duration of treatment / exposure:
4 hours
Observation period:
14 days
Number of animals:
3
Details on study design:
The test substance was applied once to skin with a patch

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 24, 48 and 72 hours
Score:
0.3
Max. score:
0
Reversibility:
fully reversible within: 14 days
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 24, 48 and 73 hours
Score:
2
Max. score:
2
Reversibility:
fully reversible within: 14 days
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 24, 48 and 72 hours
Score:
2
Max. score:
2
Reversibility:
fully reversible within: 14 days
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 24, 48 and 72 hours
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: 72 hours
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 7 days
Other effects:
Dry and rough skin was observed in 2 animals from 72 hours up to 7 days p.a.
Scaly skin observed in one animal from 72 hours up to 7 days p.a.

Any other information on results incl. tables

NA-DETA should be classified according to Directive 67/548/EEC but not to Regulation (EC) No 1272/2008.

For practical reasons it is proposed to classifiy according to both regulation.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
NA-DETA was evaluated as irritating to skin according to DSD 67/548/EEC and should be classified as Xi; R38.


Executive summary:

The skin irritation potential of NA-DETA was investigated according to OECD 404. NA-DETA induced moderate erythema and oedema, justifying the classification. The effects were reversible within 14 days of observation period.

NA-DETA should be classified as Xi;R38 according to DSD 67/548/EEC and for practical reasons it is proposed to classify as Warning, Category 2; H315 according to Regulation (EC) No 1272/2008.